Safety and Efficacy of Neuroform for Treatment of Intracranial Aneurysms: A Prospective, Consecutive, French Multicentric Study

Abstract

BACKGROUND AND PURPOSE: Endovascular embolization of wide-neck intracranial aneurysms can be technically challenging, especially when the anatomy is complex. Stent reconstruction of the parent artery is commonly used to treat wide-neck and bifurcated aneurysms. The main objective of this study was to investigate the periprocedural and midterm morbidity and mortality results of this procedure. MATERIALS AND METHODS: SENAT is a consecutive, prospective, multicentric study. Patients with unruptured cerebral aneurysms who underwent endovascular treatment with the Neuroform stent system were recruited and recorded. Technical outcomes and complications were also assessed. The midterm anatomic results were re-evaluated at 12–18 months. RESULTS: A total of 113 stents were used to treat the 107 aneurysms in 107 patients. The mean width of the aneurysm sac was 6.2 mm, and the mean diameter of aneurysm neck was 4.5 mm. The complete occlusion rate postprocedure was 66.4%. The rate of progressive occlusion at 12–18 months was 14%, and the rate of recurrence was 9.7%. The rate of subsequent treatment was 4%. The thromboembolic rate in the periprocedural period was 3.7%, and the rate of delayed TE events was 3%. Overall, the mortality rate at 12–18 months was 1%, and the permanent morbidity rate was 1%. CONCLUSIONS: Stent-assisted coiling with the Neuroform stent system provides a high level of occlusion with low rates of subsequent treatment despite a predominant population of patients with wide-neck aneurysms. Morbidity and thromboembolic rates were comparable to studies investigating stand-alone coiling.